molecular diagnostics
FDA Clears Two Molecular Diagnostic Products From Qiagen
Qiagen has earned 510(k) clearances for two of its IVD products: the real-time PCR instrument Rotor-Gene Q MDx, and the artus Infl A/B RG RT-PCR Kit, a compatible test for the detection of Influenza A/B. The Rotor-Gene Q MDx instrument is intended for IVD use with FDA-cleared or -approved nucleic acid tests in clinical laboratories. The platform uses a unique centrifugal rotary design to amplify and quantify DNA molecules, enabling a “near-perfect” well-to-well thermal and optical...
Meridian Bioscience Awarded Agreement with GPO Premier for Molecular Diagnostics
Meridian Bioscience Inc. announced it has signed a new group purchasing agreement with Premier healthcare alliance to offer Illumigene C. difficile and Illumigene Group B Streptococcus to its members at specially negotiated pricing. Premier is a group purchasing organization (GPO) that serves upward of 2500 U.S. hospitals and 81,000-plus other healthcare sites. This new agreement allows facilities doing business with Premier to implement rapid, sensitive molecular...
Enzo Biochem Launches Colorectal Cancer Test
Enzo Biochem Inc. announced the launch of the ColonSentry test for assessing a patient’s risk of having colorectal cancer, the first in a pipeline of new molecular diagnostic products the Company plans for the medical community. “As a pioneer in the use of genomic and genetic information as a catalyst for diagnostic products for delivering better healthcare, the availability of ColonSentry, which only recently received New York State...
GenMark + Advanced Liquid Logic to Develop All-Electronic, Fully Integrated Dx Platform
GenMark Diagnostics Inc. and Advanced Liquid Logic Inc. are collaborating to develop an all-electronic, fully integrated IVD platform combining Advanced Liquid Logic’s proprietary electrowetting technology and GenMark’s proprietary electrochemical detection. GenMark is a provider of automated, multiplex molecular-dx testing systems that detect and measure DNA and RNA targets to diagnose disease and personalize patient treatment. The company currently markets three FDA-cleared IVD...
Ambry Genetics Introduces Sequencing Test
Ambry Genetics announced the First-Step Exome test. The First-Step Exome reports on all Human Gene Mutation Database (HGMD)-defined genes. The role of genes in human disease has only been defined in approximately 20% (~4,400 of ~20,000 genes) of the human genome. The First-Step Exome analyzes the DNA sequence of the exons (coding regions) and flanking intronic regions of these ~4,400 genes. Ambry Genetics believes that the targeted exome sequencing provided by the First-Step Exome is...
Quidel Receives FDA Clearance for Molecular Flu Assay for Use on Cepheid SmartCycler
Quidel Corp. has received 510(k) clearance from FDA for its Quidel Molecular Influenza A+B Assay for the detection of influenza A and B for use with Cepheid's SmartCycler PCR system. This product is one of several assays from Quidel's expanding molecular diagnostics programs. The Quidel Molecular product line offers PCR reagent kits for use by molecular diagnostic laboratories with their existing thermocyclers. These kits include features that provide for simple transport and storage, ease-of-...
Bioline Receives Clearance for Streptococcus Molecular Test
Bioline, a wholly-owned subsidiary of Meridian Bioscience Inc., has received clearance from the Therapeutic Goods Administration (TGA) for its illumigene Group B Streptococcus (GBS) test, the newest molecular product on the illumigene platform. The approval in Australia for the commercialization of illumigene GBS comes on the heels of the recent FDA clearance in the United States. illumigene GBS utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Streptococcus...
Quest Diagnostics Launches Molecular Test for Kidney Organ Transplant Rejection
Quest Diagnostics (announced the availability of the industry's first molecular blood test for identifying renal (kidney) organ-transplant rejection. The Renal Transplant Monitoring laboratory-developed test is designed to help physicians detect kidney failure weeks before conventional tests or clinical symptoms signify damage. The test may potentially improve patient care for kidney transplant patients while helping to lower sizeable healthcare costs associated with renal transplant...
Quidel Receives CE Mark for Respiratory Molecular Diagnostic Test
Quidel Corp. has received the CE Mark for the Quidel Molecular RSV + hMPV assay for the detection of respiratory syncytial virus (RSV) and human metapneumovirus (hMPV). The CE Mark for Quidel's molecular RSV + hMPV assay clears the way for the launch of another infectious disease molecular test offering in Europe. The assay distinguishes between RSV and hMPV, two different viruses that cause respiratory infections with very similar symptoms. Quidel Molecular RSV + hMPV is one of several...
Reproductive-health startup scores $1.5M in series-A funding
Celmatix Inc., a New York City-based developer of molecular diagnostic products to assess genetic indicators of age-independent egg quality in women, just closed $1.5-million series-A funding led by Topspin Partners. The company says it will use the funding to continue R&D on its flagship product, FertilArray, a noninvasive diagnostic test that uses genetic biomarkers to detect infertility in some women. Piraye Yurttas Beim, Celmatix cofounder and CSO, was quoted in a company press release...